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    Acadia Pharma (ACAD) PDUFA of Nuplazid for Parkinson's disease psychosis

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    Biotech Forecast
    Clinical and Regulatory
    Event Type: PDUFA
    Timing: 05/01/2016
    Designation(s): Breakthrough Therapy, Priority Review

    This event is set for a specific date and makes planning easier. However, specific dates may change.
    FDA special designations may increase the likelihood of success and decrease the time to approval.
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    Disease and Treatment
    Disease: Neurology
    Indication: Parkinson's Psychosis
    Lead Indication?: Yes
    Treatment Name: NUPLAZID™ (pimavanserin)

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: ACADIA Pharmaceuticals
    Stock Symbol: ACAD
    Shares Traded: NASDAQ

    The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
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    Event Status
    Event Outcome: Ongoing
    Event Discussion: Forums
    Event Announcement(s): http://ir.acadia-pharm.com/phoenix.zhtml?c=125180&p=irol-newsArticle&ID=2133696
    Partnership: No

    Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
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    Detailed Event Description from Company Announcement

    Quote

    The Prescription Drug User Fee Act (PDUFA) action date for completion of FDA review of the NUPLAZID NDA is May 1, 2016. The FDA has granted the NUPLAZID NDA Priority Review status and designated NUPLAZID for the treatment of psychosis associated with Parkinson’s disease as a Breakthrough Therapy.

     

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    Biotech Forecast

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    NUPLAZID is a much needed treatment for psychosis sand therefore the FDA may grant approval with a follow on post approval study.

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